A Study of 28431754 (Canagliflozin) on Gastrointestinal Glucose Absorption and Metabolism in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

The purpose of this study is to evaluate the effect of canagliflozin on gastrointestinal glucose absorption in healthy volunteers.

Key facts

Study ID

NCT01173549

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

26

Starts

2010-11-01

Expected to finish

2011-09-01

Last updated by the study team

2012-01-02

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Have a Body Mass Index (BMI) between 20 and 27 kg/m2 (inclusive) and a body weight not less than 50 kg
• Be healthy on the basis of physical examination including medical history, vital signs, 12-lead ECG, and all other screening lab tests performed at Screening and Admission
• Agree (if men) to use a double barrier method of birth control (e.g., condom for them and use of spermacide with diaphragm, hormonal contraceptives or intrauterine devices by female partner) during the study and for three months following the last dose of study medication, and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
• Willing/able to adhere to the prohibitions and restrictions specified in this protocol
• Must have signed an informed consent form.

You may not qualify if…

• Have a history of, or currently active, illness or medical condition or disorder that the Investigator considers to be clinically significant
• Has been a smoker or tobacco user within the past 6 months
• Have a history of recent major surgery (within 6 months of study start)
• Tested positive for serology: hepatitis B surface antigen (HBsAg), hepatitis C antibodies (anti-HCV) or human immunodeficiency virus (HIV) antibodies
• Fasting plasma glucose > 110 mg/dL
• Have a history of alcohol or drug abuse within 2 years prior to Screening or a positive test for alcohol and/or drugs of abuse (including but not limited to barbiturates, opiates, cocaine, cannabinoids, amphetamines,MDMA (Ecstasy) and benzodiazepines) at Screening

Where it is running

• Study site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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